Heartvista, Inc. - FDA 510(k) Cleared Devices

Heartvista, Inc. develops intelligent software to streamline MRI examinations. The company specializes in Radiology devices, with a focus on automating cardiac MRI acquisition. Heartvista's technology enables clinicians to perform accurate, high-quality scans consistently and rapidly.

Heartvista received 6 FDA 510(k) clearances from 6 total submissions between 2014 and 2021. All submissions were in the Radiology category. The company's cleared devices include the RTHawk and RTHawk Workstation platforms, which automate cardiac imaging workflows.

Heartvista has been inactive since 2021 with no recent FDA submissions. This profile reflects the company's historical regulatory record and contributions to cardiac MRI automation technology.